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Aurobindo Pharma shares in focus on 8 observations from USFDA

08 Sep , 2025   By : Debdeep Gupta


Aurobindo Pharma shares in focus on 8 observations from USFDA

Aurobindo Pharma share will remain in focus on September 8 following the company received eight observations from the United States Food and Drug Administration (USFDA).


The USFDA inspected company's Unit-XII, including oral solids and injectable manufacturing unit, situated at Bachupally, Medchal Malkajgiri District, Telangana from August 25 to September 05, 2025.


At the end of the current inspection, a ‘Form 483’ was issued with a total of 8 observations for both (oral solids & injectable).


All observations are procedural in nature and will respond to the US FDA within the stipulated timelines, company said.


On August 29, the USFDA issued a Form 483 with five observations on inspecting Unit-I, an API manufacturing facility of the company’s subsidiary Apitoria Pharma at Sangareddy, Telangana, during August 21–29.


The observations were procedural in nature, and no data integrity issues were reported.


In the previous trading session, the share closed at Rs 1,044.40, up Rs 9.15, or 0.88 percent.


The share touched a 52-week high of Rs 1,592.55 and a 52-week low of Rs 994.35 on 13 September, 2024 and 07 April, 2025, respectively.


Currently, the stock is trading 34.42 percent below its 52-week high and 5.03 percent above its 52-week low.


The market capitalisation of the company stands at Rs 60,658.92 crore.


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